Neurocrine Biosciences has started a Phase II clinical trial of NBI-98854 (Valbenazine), a highly selective small molecule Vesicular Monoamine Transporter 2 (VMAT2) inhibitor, to treat Tourette syndrome in adults.
VMAT2 is a protein concentrated in the human brain that is primarily responsible for re-packaging and transporting monoamines in pre-synaptic neurons.
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The initiation of this trial has expanded the clinical efforts for NBI-98854 in adults with Tourette syndrome.
Around 90 adults will be enrolled in this randomised, double-blind, placebo-controlled, multi-dose, parallel group Phase II trial (T-Forward study).
In the trial, patients will receive once-daily dosing of NBI-98854 during an eight-week treatment period to evaluate the safety, tolerability and efficacy of the VMAT2 inhibitor.
The trial’s primary endpoint is a change from baseline of placebo versus active scores using the Yale Global Tic Severity Scale at the end of week eight.
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By GlobalDataResults from this trial are expected to be reported later in 2016.
Neurocrine Biosciences chief medical officer Dr Christopher O’Brien said: "Evaluation of Valbenazine in adults with Tourette syndrome is another important step in fully exploring its potential in movement disorders.
"We look forward to our T-Force study readout of children and adolescents with Tourette’s during this quarter, and our anticipated NDA filing of NBI-98854 for tardive dyskinesia in 2016."
The three-arm trial will evaluate up to 90 patients over eight weeks of dosing followed by two weeks off-drug at approximately 40 study centres in the US.
Tourette symptoms, a neurological disorder, will also be evaluated through the Premonitory Urge for Tics Scale, as well as Clinical Global Impression of Change scales, among others.
This disorder consists of rapid, non-rhythmic stereotyped motor and vocal tics.
The company has two distinct investigational new drug applications (INDAs) related to NBI-98854, tardive dyskinesia and Tourette syndrome, open with the Division of Psychiatry Products at the FDA.
The FDA has granted breakthrough therapy designation for NBI-98854 in the treatment of tardive dyskinesia and expects to file a new drug application (NDA) for tardive dyskinesia in 2016.
